Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Benadryl Children's Dry Coughs
Active Ingredient(s): Pholcodine 1mg/mL
Dosage Form: Oral solution
New Zealand Sponsor: Warner-Lambert Consumer Healthcare Pty Lmited
Manufacturer(s): PharmAction Manufacturing Pty Limited, Laverton North, Victoria, Australia
Product: Doxorubicin Hexal
Active Ingredient(s): Doxorubicin hydrochloride 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Hexal New Zealand Pty Limited
Manufacturer(s): Ebewe Arzneimittel GmbH, Unterach, Austria
Product: Etidrate
Active Ingredient(s): Disodium etidronate 200mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Pharmaceuticals, Etobicoke, Ontario, Canada
Product: Etidrate
Active Ingredient(s): Disodium etidronate 400mg
Dosage Form: Tablet
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Genpharm Inc., Pharmaceuticals, Etobicoke, Ontario, Canada
Product: Listerine Tartar Control Antiseptic Mouthwash
Active Ingredient(s): Alcohol 22.5%v/v
Benzoic acid 0.105%w/v
Cineole 0.092%w/v
Thymol 0.064%w/v
Zinc chloride 0.09%w/v
Dosage Form: Mouthwash
New Zealand Sponsor: Warner-Lambert Consumer Healthcare Pty Limited
Manufacturer(s): Parke Davis Pty Limited, Caringbah, Sydney, New South Wales, Australia
Product: Psytixol Injection
Active Ingredient(s): Flupenthixol decanoate 100mg/mL
Dosage Form: Injection (depot)
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck KGaA, Darmstadt, Germany
Product: Psytixol Injection
Active Ingredient(s): Flupenthixol decanoate 200mg/mL
Dosage Form: Injection (depot)
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck KGaA, Darmstadt, Germany
Product: Psytixol
Active Ingredient(s): Flupenthixol decanoate 20mg/mL
Dosage Form: Injection (depot)
New Zealand Sponsor: Pacific Pharmaceuticals Limited
Manufacturer(s): Merck KGaA, Darmstadt, Germany
Dated this 9th day of August 2000.
G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).